MAP BioPharma

On January 16, 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) published an update to pharmaceutical companies regarding the preparations for the UK to exit the European Union (EU).

This follows the publication on 8 December 2017 of a joint report by UK and EU negotiators on progress during the first phase of exit negotiations. “Sufficient progress” is said to have been made to allow the second stage of negotiations to begin, and guidelines for the second phase have been agreed. The guidelines set out the need for the UK and the EU to complete work on all withdrawal issues and to initiate drafting of the Withdrawal Agreement.

The proposal for a time-limited implementation period based on the existing structure of EU rules and regulations has been acknowledged within the EU guidelines, with the aim of continuing UK access to the EU market on current terms throughout this period. The importance of an implementation period to provide certainty and continuity to business and individuals is recognised by both parties. Additional negotiating directives on transitional agreements are expected to be adopted by the EU in January 2018. During 2018 the UK expects to be able to agree the details with the EU.

The guidelines reaffirm both the UK’s and the EU’s desire to maintain a close working relationship in the interests of public health and safety, and to ensure continued access to innovative medicines whilst ensuring patient safety through the strongest regulatory framework.

MHRA will continue to work with the European Medicines Agency (EMA) in planning for the UK’s withdrawal from the EU. The regulatory relationship between the UK and European networks remains unchanged at present: the UK will continue to fulfil its responsibilities as a full member of the EU. This will include bidding for EMA work. The UK will create strategies to manage the possibility of various outcomes at the end of its membership in March 2019. For example, MHRA will put forward UK bids in conjunction with other member states through the centralised procedure to ensure business continuity where procedures are likely to run beyond this date. MHRA has committed to completing all assessments under evaluation by the time the UK departs from the EU, with all assessment reports available to the networks. The UKs Official Control Authority Batch Release (OCABR) responsibilities as part of the Official Medicines Control Laboratory (OMCL) network for human biologicals will continue at present.